Published: February 2012
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide conforms to GAMP® 5 standards and terminology and reflects ICH Q8, Q9, and Q10, Quality by Design, and Process Analytical Technology principles. The Guide contains information on cloud computing, automated testing, and non-linear development and focuses on risk-based approaches that help suppliers to optimize their products and end-users to focus on critical areas.
|Available in German|
|GAMP 5: Ein risikobasierter Ansatz zum Test GxP-von GxP-Systemen|
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